Label: NICORETTE- nicotine polacrilex lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 68151-5980-1 - Packager: Carilion Materials Management
- This is a repackaged label.
- Source NDC Code(s): 0135-0508
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 6, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each lozenge)(2mg)
- Active ingredient (in each lozenge)(4mg)
- Purpose
- Use
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Warnings
If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.
Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.
Ask a doctor before use if you have
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- heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
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- high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
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- stomach ulcer or diabetes
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- history of seizures
Ask a doctor or pharmacist before use if you are
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- using a non-nicotine stop smoking drug
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- taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
Stop use and ask a doctor if
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- mouth problems occur
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- persistent indigestion or severe sore throat occurs
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- irregular heartbeat or palpitations occur
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- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
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- you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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Directions (2mg Lozenge)
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- if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
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- before using this product, read the enclosed User’s Guide for complete directions and other important information
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- begin using the lozenge on your quit day
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- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge
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- if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:
Weeks 1to 6
Weeks 7 to 9
Weeks 10 to 12
1 lozenge every 1 to 2 hours
1 lozenge every 2 to 4 hours
1 lozenge every 4 to 8 hours
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- nicotine lozenge is a medicine and must be used a certain way to get the best results
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- place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
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- you may feel a warm or tingling sensation
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- occasionally move the lozenge from one side of your mouth to the other until completely dissolved
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- do not eat or drink 15 minutes before using or while the lozenge is in your mouth
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- to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
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- do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
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- do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
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- it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.
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Directions (4mg Lozenge)
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- if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
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- before using this product, read the enclosed User’s Guide for complete directions and other important information
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- begin using the lozenge on your quit day
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- if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge
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- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:
Weeks 1to 6
Weeks 7 to 9
Weeks 10 to 12
1 lozenge every 1 to 2 hours
1 lozenge every 2 to 4 hours
1 lozenge every 4 to 8 hours
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- nicotine lozenge is a medicine and must be used a certain way to get the best results
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- place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
- •
- you may feel a warm or tingling sensation
- •
- occasionally move the lozenge from one side of your mouth to the other until completely dissolved
- •
- do not eat or drink 15 minutes before using or while the lozenge is in your mouth
- •
- to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
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- do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
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- do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
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- It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- NICORETTE (NICOTINE POLACRILEX) LOZENGE
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INGREDIENTS AND APPEARANCE
NICORETTE
nicotine polacrilex lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68151-5980(NDC:0135-0508) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 2 mg Inactive Ingredients Ingredient Name Strength POLACRILIN (UNII: RCZ785HI7S) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM CARBONATE (UNII: 45P3261C7T) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 10mm Flavor MINT Imprint Code M Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68151-5980-1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022360 03/01/2010 Labeler - Carilion Materials Management (079239644) Establishment Name Address ID/FEI Business Operations Carilion Materials Management 079239644 REPACK(68151-5980)
